A randomised phase II double blind placebo controlled trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer (NSCLC) with multiple brain metastases - TACTIC

niversity College London0 sites144 target enrollmentDecember 7, 2006

Overview

No summary available.

Registry

who.int

Start Date

December 7, 2006

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity College London

•a) Histologically or cytologically confirmed NSCLC. A biopsy of metastatic disease in the brain is not required for study enrolment.
•b) Patients with newly diagnosed single or multiple brain metastases in whom immediate chemotherapy is not required for palliation of systemic extra\-cranial disease. Patients with a solitary brain metastasis are only eligible for the trial providing they are not suitable for stereotactic radiotherapy or surgical resection.
•c) Diagnosis of brain metastases must be confirmed on MRI or contrast CT scan.
•d) Able to start treatment within 4 weeks of the baseline measurement scans of the brain, chest \& abdomen.
•e) Patients with post\-craniotomy incomplete resection will be permitted.
•f) No prior cranial radiotherapy.
•g) \= 28 days from any chemotherapy to Day 1 of trial treatment.
•h) Clinician certain of the role of WBRT.
•i) Glasgow Coma Score \=14\.
•j) Karnofsky performance status \= 70, RTOG RPA class I and II (modified by age to \<76 years).

•a) Presence of a solitary brain metastasis suitable for stereotactic radiosurgery or surgical resection.
•b) Patients who require immediate chemotherapy for symptom control.
•c) Clinician certain that WBRT will NOT be of benefit.
•d) Clinician uncertain of the role of WBRT.
•e) Previous treatment with any EGFR anti\-cancer therapy (e.g. Tarceva, Iressa or Cetuximab).
•f) Previous treatment for brain metastases (radiosurgery, radiotherapy or chemotherapy) \- however prior radiotherapy or surgery to the primary tumour and/or systemic treatment to metastatic sites of disease is acceptable.
•g) Glasgow Coma Score \< 14\.
•h) Pregnant or lactating women.
•i) Evidence of other significant laboratory finding or concurrent uncontrolled medical illness which in the opinion of the investigator would interfere with protocol treatment or results comparison or render the subject at high risk from treatment complications. For example:
•\-Severe uncontrolled infection